Site Name: USA - Pennsylvania - King of Prussia Posted Date: Nov 17 2021 Biopharmaceutical Analytical Technical Operations Lead Are you interested in contributing your detailed analytical knowledge of biopharmaceuticals while managing cross-functional teams that are responsible for GSK's analytical strategies for projects in various phases of development ranging from Pre-Candidate Selection to Commercialization? If so, this Biopharmaceutical Analytical Technical Operations Lead could be an ideal opportunity to explore. As a Biopharmaceutical Analytical Technical Operations Leader, you will be proficient in analytical technology transfer, method optimization, method validations and have a basic understanding of Quality by Design (QbD) principles as applied to biopharmaceuticals. This role will provide YOU the opportunity to lead key project activities and progress YOUR career. You will be a key leader on an analytical project team helping to delivering critical medications to patients. These responsibilities include some of the following: Manage clinical and commercial specifications Ensure methods are fit for their intended purpose Lead technology transfers, qualifications, and validations as required Lead troubleshooting initiatives and GEMBAs across testing laboratories Lead change management and quality documentation activities This position can give you some of the experience required to progress into more senior project leadership or regulatory roles. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: BS/MS with more than 5 years or a Ph.D. with 1-3 years of experience in biotechnology or pharmaceutical industry Preferred Qualifications: If you have the following characteristics, it would be a plus: In-depth knowledge and/ or hands-on experience in various protein separation and other characterization techniques such as CGE, cIEF, HPLC/UHPLC, mass spectrometry, and functional assays Data integrity and documentation principles Experience leading change management Knowledge and experience with QbD approaches to analytical lifecycle management including critical quality attributes, analytical target profiles, platform methods, specifications, and analytical testing strategies Experience with contributing to regulatory files IND/BLA etc. Experience with biopharmaceutical development in a biotech environment. Experience with managing project matrix team and cross-functional task forces Good knowledge of protein and oligosaccharide separation methods, and sound understanding of protein structure and function are essential to this position The candidate is expected to be highly motivated and an instinctive team player with excellent communication skills, both written and verbal Why GSK? At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggest changes we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of disease together - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients - so we deliver what matters better and faster; accountable for impact - with clear ownership of goals and support to succeed; and where we do the right thing. So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together. *LI-GSK If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). 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